Uterine Fibroids (Leiomyoma)NCT07480785
TEAS Combined With Triple Antiemetic Drugs to Prevent PONV in High-Risk Patients
A study testing transcutaneous electrical acupoint stimulation and triple antiemetic drugs in people with Uterine Fibroids (Leiomyoma) and Ovarian Tumors, run by Zhejiang University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetics for postoperative nausea and vomiting (PONV) in high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyoma), Ovarian Tumors, Gallstones
- What is being tested?
- transcutaneous electrical acupoint stimulation and triple antiemetic drugs
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 780 participants
- Where
- 1 siteChina
- Study dates
- 16 Jan 2026to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women scheduled for laparoscopic surgery ；
- Aged 18-65 years；
- ASA Class I-III；
- Apfel score ≥ 3 (female sex, non-smoker, history of PONV and/or motion sickness).
Who cannot join
- Patients with a history of allergy to the investigational drug or contraindications；
- Long-QT syndrome ；
- Pregnancy, lactation, or menstruation ；
- Current smoker；
- Nausea/vomiting or use of antiemetics, opioids, or systemic corticosteroids within 24 h before surgery；
- Requirement for post-operative sedation and mechanical ventilation ；
Show all 15Show fewer
- Severe renal or hepatic impairment ；
- Psychiatric or neurological disorder ；
- Vertebrobasilar insufficiency；
- Vestibular disease；
- Language or communication barrier ；
- Skin lesion or infection at the acupoint stimulation site ；
- Upper-limb nerve injury ；
- Implanted cardiac pacemaker or defibrillator ；
- Participation in another clinical trial within the past 4 weeks.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Diansan Su, PhD, +8618616514088, diansansu@yahoo.com
About this study
Official title: Transcutaneous Electrical Acupoint Stimulation Combined With Triple Antiemetic Drugs for Postoperative Nausea and Vomiting in High-Risk Patients: A Multicenter Randomized Controlled Trial
The goal of this clinical trial is to evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetics for postoperative nausea and vomiting (PONV) in high-risk patients.
The primary question it seeks to answer is:
Does TEAS combined with triple antiemetics further reduce the incidence of PONV in high-risk subjects? Researchers will compare active TEAS with sham stimulation to determine whether the addition of TEAS to dexamethasone, palonosetron, and droperidol lowers the PONV rate beyond that achieved by the triple-drug prophylaxis alone.
Read the detailed description
780 female patients, aged between 18 to 65 y, who are scheduled for elective laparoscopic surgery requiring general anesthesia, will be randomly allocated to acustimulation group (Group TEAS), or the control group.
In Group TEAS, a surface electrode will be applied to the P6 and L14 acupoint 30 min before induction. An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold. The stimulation will be maintained until the patient is discharged from the operation. In the control group the same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.
A standardized anesthetic protocol will be followed. In all groups, dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure. After surgery, metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.
The patients shall be unaware of the group assignments. An anesthesiologist, who are trained for the study and blinded to the randomization, will collect the data.
- Conditions
- Uterine Fibroids (Leiomyoma), Ovarian Tumors, Gallstones
- Being tested
- transcutaneous electrical acupoint stimulation, Sham transcutaneous electrical acupoint stimulation, triple antiemetic drugs
- Keywords
- postoperative nausea and vomiting, transcutaneous electrical acupoint stimulation, high-risk patients with PONV
- Medical subject headings
- Leiomyoma, Ovarian Neoplasms, Gallstones, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous electrical acupoint stimulationDevice
Using the Huatuo brand electronic acupuncture therapy device (Model: SDZ-Ⅲ, produced by Suzhou Medical Equipment Co., Ltd., China), bilateral upper limb acupoints P6+L14 were selected. Approximately 30 minutes before anesthesia induction, the electrodes were connected with the initial current set at 1 milliampere and frequency at 2/100 Hz. The current intensity was gradually increased until the patient felt pain or reached the discomfort threshold (ranging between 6 to 10 mA), and the stimulation was maintained until the patient was discharged from the PACU.
Sham transcutaneous electrical acupoint stimulationDevice
The same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.
triple antiemetic drugsDrug
Dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure.
| Study group | Role | What they receive |
|---|---|---|
| The TEAS group | Experimental | The TEAS group，Nei-guan (PC6) and He-gu (LI4) were stimulated by a transcutaneous acupoint electrical stimulation instrument approximately 30 minutes before anesthesia induction until the patient is discharged from the operating room. Receives: Device: transcutaneous electrical acupoint stimulation; Drug: triple antiemetic drugs |
| The control group | Sham comparator | The same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute. To ensure complete blinding, both groups were covered with opaque sheets over the percutaneous acupoint electrical stimulation device. Receives: Device: Sham transcutaneous electrical acupoint stimulation; Drug: triple antiemetic drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after operation.
The number of episodes of nausea, retching and vomiting within 24 hours after operation
Measured: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation
Secondary outcomes (3)
Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively
Nausea score: The severity of PON was measured using a visual analog scale (VAS), with 0 indicating no symptoms and 10 representing the most severe imaginable symptoms.
Measured: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Number of Participants Experiencing Postoperative Vomiting in 48 h Postoperatively
including retching and vomiting
Measured: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Need of Postoperative Metoclopramide
Need of Postoperative Metoclopramide
Measured: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study start16 Jan 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Fibroids (Leiomyoma)Studies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Jinhua Central Hospital, Huzhou Central Hospital, The First People's Hospital of Huzhou
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07480785
- Sponsor's protocol ID
- ZJU_2025B1460
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Acupoint Stimulation Combined With Triple Antiemetic Drugs for Postoperative Nausea and Vomiting in High-Risk Patients: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07480785
- Acronym / sponsor ID
- ZJU_2025B1460
- Conditions
- Uterine Fibroids (Leiomyoma), Ovarian Tumors, Gallstones
- Keywords
- postoperative nausea and vomiting, transcutaneous electrical acupoint stimulation, high-risk patients with PONV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 780 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Jinhua Central Hospital, Huzhou Central Hospital, The First People's Hospital of Huzhou
- Study start
- 16 Jan 2026 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 18 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to evaluate the effects of transcutaneous electrical acupoint stimulation (TEAS) combined with triple antiemetics for postoperative nausea and vomiting (PONV) in high-risk patients.
The primary question it seeks to answer is:
Does TEAS combined with triple antiemetics further reduce the incidence of PONV in high-risk subjects? Researchers will compare active TEAS with sham stimulation to determine whether the addition of TEAS to dexamethasone, palonosetron, and droperidol lowers the PONV rate beyond that achieved by the triple-drug prophylaxis alone.
Detailed description
780 female patients, aged between 18 to 65 y, who are scheduled for elective laparoscopic surgery requiring general anesthesia, will be randomly allocated to acustimulation group (Group TEAS), or the control group.
In Group TEAS, a surface electrode will be applied to the P6 and L14 acupoint 30 min before induction. An operator will set electric stimulating current at 1mA with frequency at 2 Hz, and gradually increased the current intensity to a little below discomfort threshold. The stimulation will be maintained until the patient is discharged from the operation. In the control group the same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute.
A standardized anesthetic protocol will be followed. In all groups, dexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure. After surgery, metoclopramide 10mg i.v. will be administered as a rescue therapy to any patient who experiences an episode of moderate or severe nausea, an episode of vomiting, and requests rescue medication.
The patients shall be unaware of the group assignments. An anesthesiologist, who are trained for the study and blinded to the randomization, will collect the data.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The TEAS group | Experimental | Device: transcutaneous electrical acupoint stimulation, Drug: triple antiemetic drugsThe TEAS group，Nei-guan (PC6) and He-gu (LI4) were stimulated by a transcutaneous acupoint electrical stimulation instrument approximately 30 minutes before anesthesia induction until the patient is discharged from the operating room. |
| The control group | Sham comparator | Device: Sham transcutaneous electrical acupoint stimulation, Drug: triple antiemetic drugsThe same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute. To ensure complete blinding, both groups were covered with opaque sheets over the percutaneous acupoint electrical stimulation device. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women scheduled for laparoscopic surgery ；
- Aged 18-65 years；
- ASA Class I-III；
- Apfel score ≥ 3 (female sex, non-smoker, history of PONV and/or motion sickness).
Key exclusion criteria (15 listed)
- Patients with a history of allergy to the investigational drug or contraindications；
- Long-QT syndrome ；
- Pregnancy, lactation, or menstruation ；
- Current smoker；
- Nausea/vomiting or use of antiemetics, opioids, or systemic corticosteroids within 24 h before surgery；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous electrical acupoint stimulationUsing the Huatuo brand electronic acupuncture therapy device (Model: SDZ-Ⅲ, produced by Suzhou Medical Equipment Co., Ltd., China), bilateral upper limb acupoints P6+L14 were selected. Approximately 30 minutes before anesthesia induction, the electrodes were connected with the initial current set at 1 milliampere and frequency at 2/100 Hz. The current intensity was gradually increased until the patient felt pain or reached the discomfort threshold (ranging between 6 to 10 mA), and the stimulation was maintained until the patient was discharged from the PACU. | Device | The TEAS group |
| Sham transcutaneous electrical acupoint stimulationThe same protocol was applied for percutaneous acupoint electrical stimulation, initiated before anesthesia induction with the minimum perceptible current (MPC) and terminated after 1 minute. | Device | The control group |
| triple antiemetic drugsDexamethasone 5mg and palonosetron 0.25mg i.v. will be given after induction, and droperidol 1.25 mg i.v. will be given during the abdominal closure. | Drug | The TEAS group, The control group |
Primary outcome
Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after operation.
Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation
The number of episodes of nausea, retching and vomiting within 24 hours after operation
3 secondary outcomes
Number of Participants Experiencing Postoperative Nausea in 48 h Postoperatively
Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Number of Participants Experiencing Postoperative Vomiting in 48 h Postoperatively
Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Need of Postoperative Metoclopramide
Time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation, 48 hours post-operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous electrical acupoint stimulation and triple antiemetic drugs in people with Uterine Fibroids (Leiomyoma) and Ovarian Tumors, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diansan Su, PhD (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Nausea,Retching and Vomiting within 24 hours after operation. (time frame: 2 hours post-operation, 6 hours post-operation, 24 hours post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.